national center for emerging and zoonotic infectious

48
Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Improving Clinical and Public Health Outcomes through National Partnerships to Prevent and Control Emerging and Re-Emerging Infectious Disease Threats CDC-RFA-CK20-2003 Application Due Date: 07/31/2020

Upload: others

Post on 09-Dec-2021

1 views

Category:

Documents


0 download

TRANSCRIPT

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Improving Clinical and Public Health Outcomes through National Partnerships to Prevent and

Control Emerging and Re-Emerging Infectious Disease Threats

CDC-RFA-CK20-2003 Application Due Date: 07/31/2020

Improving Clinical and Public Health Outcomes through National Partnerships to Prevent and

Control Emerging and Re-Emerging Infectious Disease Threats CDC-RFA-CK20-2003

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

1 of 46

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA-CK20-2003. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes. A. Federal Agency Name: Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title: Improving Clinical and Public Health Outcomes through National Partnerships to Prevent and Control Emerging and Re-Emerging Infectious Disease Threats C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)). New – Type 1; competitive, non-research

D. Agency Notice of Funding Opportunity Number: CDC-RFA-CK20-2003 E. Assistance Listings (CFDA) Number: 93.318 F. Dates: 1. Due Date for Letter of Intent (LOI): 07/14/2020 2. Due Date for Applications: 07/31/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov. 3. Date for Informational Conference Call: July 7, 2020 at 4:00 PM – 5:00 PM ET https://cdc.zoomgov.com/j/1612701276?pwd=VytvRXI0aGFYWGJ4Um5lb1ord3BEdz09 Password: CK20-2003 Or Telephone: Dial(for higher quality, dial a number based on your current location): US: +1 669 254 5252 or +1 646 828 7666 Webinar ID: 161 270 1276, Password: 580384 International numbers available: https://cdc.zoomgov.com/u/acI3CElOyH

G. Executive Summary: 1. Summary Paragraph:

2 of 46

Through this Notice of Funding Opportunity (NOFO), CDC will continue to protect America from health, safety and security threats, both foreign and in the U.S. This NOFO supports NCEZID’s strategic priorities to prevent the spread of infectious disease. This NOFO is intended to establish a roster of organizations that would be pre-identified and pre-approved for rapid funding to address emerging and re-emerging infectious disease threats through the program strategies. Organizations should have the capacity to reach frontline personnel to inform the development, adaptation, and use of guidance for infectious disease prevention and control. The organizations include, but is not limited to clinicians, other healthcare professionals, healthcare systems, and other organizations and institutions responsible for patient care and infectious disease prevention and control in the United States. This NOFO will establish an Approved-But-Unfunded (ABU) list of recipients, which will be used to effectively respond to public health threats. There is limited funding available at the time of this announcement. Additional funding will be contingent upon the availability of appropriations, at CDC’s sole discretion. CDC will provide additional information to ABU recipients, as public health needs arise.

a. Eligible Applicants: Open Competition b. NOFO Type: Cooperative Agreement c. Approximate Number of Awards: 24 Approximately 5-10 applicants will initially be awarded in response to this NOFO. The initial recipients will respond to at least two of five program strategies in response to COVID-19. All other approved applicants will be added to the ABU roster listing. ABUs will be funded in response to other emerging and re-emerging public health threats as the need arise. Applicants may apply for 2 and/or any combination of the 5 strategies.

d. Total Period of Performance Funding: $0 This amount is subject to the availability of funds. It is not possible to approximate an amount of funding due to the nature of this NOFO (i.e., the intent to establish a quick funding mechanism for pre-approved recipients faced with a public health threat).

e. Average One Year Award Amount: $1,000,000 f. Total Period of Performance Length: 5 g. Estimated Award Date: 09/30/2020 h. Cost Sharing and / or Matching Requirements: N No. Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

3 of 46

a. Overview The Centers for Disease Control and Prevention works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. The proposed cooperative agreement would fund organizations that reach professionals at the front-line of preventing and controlling the spread of emerging and re-emerging infectious disease threats such as COVID-19, including clinicians, other healthcare professionals, healthcare systems, and other organizations and institutions responsible for infectious disease prevention and control in U.S. communities and across health and occupational settings. This NOFO is intended to establish a roster of organizations that would be pre-identified and pre-approved for rapid funding to undertake activities set forth by this funding opportunity. This NOFO will establish an Approved-But-Unfunded (ABU) list of recipients. A limited amount of funding is available at the time of this award, with additional funding made available as public health threats emerge. This ABU list will be utilized by CDC to effectively respond to, manage, and address the identified public health threat, in partnership with national and regional organizations. Applications seeking to conduct activities outside the scope of the program activities will be deemed non-responsive and will not be considered. Under the proposed umbrella cooperative agreement, CDC would provide funding, as available, in support of a set of strategies that target prevention and control of emerging and re-emerging infectious diseases, including COVID-19. Collaborative activities would extend from the following program strategies:

1. DISSEMINATE AND ADOPT – Support CDC in the dissemination and adoption or implementation of guidance, clinical guidelines, and best practices for the prevention and control of emerging and re-emerging infectious diseases. Non-CDC documents should be shared with CDC for federal purposes, CDC 45 CFR 75.322.

2. INFORM AND ADAPT – Inform and support CDC in the development and adaptation of guidance, tools, and best practices, including collecting and communicating individual expert opinions that can inform updates to existing guidance that consider the needs of specific patient populations, clinical specialties, and industry sectors.

3. TARGET AND TRAIN – Engage frontline personnel and lead training in CDC best practices for the broader workforce supporting the prevention and control of emerging and re-emerging infectious diseases. Target guidance and tools to better reach communities or populations at increased risk for infectious diseases and reduce disease spread in targeted workplaces or settings.

4. INTEGRATE AND EXTEND – Develop integrated and cross-sub-specialty networks for information sharing, problem-solving, and sharing of promising practices, including the development of rapid or living learning networks. Extend networks to reach populations that are at increased risk for infectious diseases.

5. EVALUATE AND IMPROVE – Evaluate the impact and effectiveness of strategies for improved infection prevention and control practices. Implement continuous improvement by assessing and monitoring performance metrics related to prevention programs and program strategy.

b. Statutory Authorities

4 of 46

This program is authorized under Public Health Service Act sections 301(a), 307 and 317, as amended [42 U.S.C. sections 241(a), 242l, and 247b]. Authority may also stem from an applicable emergency supplemental appropriation; such appropriation and any requirements and/or limitation associated with that emergency supplemental will be added to the notice of award. P.L. 116-123 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 Pub. L. [March 6, 2020] P.L 116–136 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub.L.[ March 27, 2020] P.L. 116-139 – Paycheck Protection Program and Healthcare Enhancement Act, 2020 [April 24, 2020]

c. Healthy People 2030

HP2030 has a goal to increase immunization rates and reduce preventable infectious diseases.

HP 2030 has many metrics related to avoiding workplace injury, which is related to any adverse infection-associated outcomes in a workplace setting.

HP 2030 has two healthcare-associated infection metrics that are specific to bloodstream infections and MRSA.

d. Other National Public Health Priorities and Strategies National Emergency COVID-19 Declaration https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/; U.S. National Strategy for Combating Antibiotic-Resistant Bacteria (https://www.cdc.gov/drugresistance/us-activities/national-strategy.html);

e. Relevant Work This cooperative agreement supports NCEZID’s strategic priorities to prevent the spread of infectious disease, and in particular Strategy 3: Enhance preparedness, outbreak detection and outbreak response, 3.2 Strengthen outbreak prevention, management and response in collaboration with clinical and public health partners.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome. CDC-RFA-CK20-2003 Logic Model: Improving Clinical and Public Health Outcomes through National Partnerships to

5 of 46

Prevent and Control Emerging and Re-Emerging Infectious Disease Threats Bold indicates period of performance outcome

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

1. DISSEMINATE AND ADOPT – Support CDC in the dissemination and adoption or implementation of guidance, clinical guidelines, and best practices for the prevention and control of emerging and re-emerging infectious diseases.

2. INFORM AND ADAPT – Inform and support CDC in the development and adaptation of guidance, tools, and best practices, including collecting and communicating individual expert opinions that can inform updates to existing guidance that consider the needs of specific patient populations, clinical specialties, and industry sectors.

3. TARGET AND TRAIN – Engage frontline personnel and lead training in CDC best practices for the broader workforce supporting the prevention and control of emerging and re-emerging infectious

1) Increased distribution of existing guidance for the prevention and control of emerging and re-emerging infectious diseases to workers in the partner’s target audience 2) Adaptation of existing guidance to increase adoption in occupations who regularly engage in the prevention and control of emerging and re-emerging infectious diseases 3) New guidance is informed by target frontline prevention and control personnel 4) Rapid/living learning networks are established that engage both infectious disease prevention and control specialists and frontline workers

1) Increased number of HCP who are trained and understand best practices for the prevention and control of infectious diseases 2) Increased adoption of guidance by workers and workplace leaders to implement best practices that protect workers and community members from infectious diseases 3) Expanded participation and reach of living-learning networks among populations in environments that increase risk for infectious diseases 4) New and existing infectious disease prevention and control resources are evaluated within the environment that they are used by evaluation professionals, with feedback from frontline workers and community members as needed

1) Fewer healthcare associated infections among patients and healthcare workers 2) Fewer community-acquired infections across public and private settings 3) Improved clinical outcomes among patients with or who are at increased risk for emerging infectious diseases

6 of 46

diseases. Target guidance and tools to better reach communities and populations at increased risk for infectious diseases and reduce disease spread in targeted workplaces or settings.

4. INTEGRATE AND EXTEND– Develop integrated and cross-sub-specialty networks for information sharing, problem-solving, and sharing of promising practices, including the development of rapid or living learning networks. Extend networks to reach populations at increased risk for infectious diseases.

5. EVALUATE AND IMPROVE – Evaluate the impact and effectiveness of strategies for improved infection prevention and control practices. Implement continuous improvement by assessing and monitoring performance metrics related to prevention practices and program strategy.

i. Purpose This cooperative agreement will ultimately improve public health and clinical outcomes through national partnerships that seek to prevent and control emerging or re-emerging infectious

7 of 46

diseases, like COVID-19. Collaborative activities would extend from program strategies that disseminate & adopt, inform & adapt, target & train, integrate & extend, and evaluate and improve the delivery of program activities related to Public Health guidance.

ii. Outcomes The outcomes below are the short-term and intermediate outcomes from the logic model that recipients are expected to make progress toward achieving during the project period. Not all outcomes will be relevant to every recipient’s project plan and will depend on the program strategies used by the recipient.

Increased distribution of existing guidance for the prevention and control of emerging and re-emerging infectious diseases to workers in the organization's target audience

Adaptation of existing guidance to increase adoption in occupations who regularly engage in the prevention and control of emerging and re-emerging infectious diseases

New guidance is informed by target frontline prevention and control personnel

Rapid/living learning networks are established that engage both infectious disease prevention and control specialists and frontline workers

Increased number of personnel who are trained and understand best practices for the prevention and control of infectious diseases

Increased adoption of guidance by workers and workplace leaders to implement best practices that protect workers and community members from infectious diseases

Expanded participation and reach of living-learning networks among populations in environments that increase risk for infectious diseases

New and existing infectious disease prevention and control resources are evaluated within the environment that they are used by evaluation professionals, with feedback from frontline workers and community members as needed

iii. Strategies and Activities Applicants should propose activities that track to at least two of the five program strategies:

1. DISSEMINATE AND ADOPT – Support CDC in the dissemination and adoption or implementation of guidance, clinical guidelines, and best practices for the prevention and control of emerging and re-emerging infectious diseases. Non-CDC documents should be shared with CDC for federal purposes, CDC 45 CFR 75.322.

8 of 46

2. INFORM AND ADAPT – Inform and support CDC in the development and adaptation of guidance, tools, and best practices, including tailoring existing guidance to the needs of specific patient populations, clinical specialties, and industry sectors.

3. TARGET AND TRAIN – Engage frontline personnel and lead training in CDC best practices for the broader workforce supporting the prevention and control of emerging and re-emerging infectious diseases. Target guidance and tools to better reach communities or populations at increased risk for infectious diseases and reduce disease spread in targeted workplaces or settings.

4. INTEGRATE AND EXTEND – Develop integrated and cross-sub-specialty networks for information sharing, problem-solving, and sharing of promising practices, including the development of rapid or living learning networks. Extend networks to reach populations that are at increased risk for infectious diseases.

5. EVALUATE AND IMPROVE – Evaluate the impact and effectiveness of all strategies for improved infection prevention and control practices. Implement continuous improvement by assessing and monitoring performance metrics related to prevention practices and program strategy.

Activities will vary based on the expertise and target audience of the applicant, and the program goals of the CDC programs funding partner work and projects.

1. Collaborations

a. With other CDC programs and CDC-funded organizations: Recipients are required to collaborate with other non-funding CDC program that may have content area expertise pertaining to the infectious disease of interest.

b. With organizations not funded by CDC: This funding opportunity may support multiple organizations to address a public health threat from an emerging or re-emerging infectious disease. Applicants should expect to coordinate with other recipients to amplify the goals of the program, as described in the program’s guidance.

2. Target Populations Target populations will vary depending on the particular public health threat(s) funded under this NOFO. This cooperative agreement should directly impact the health of the public, through prevention and control activities within the occupational field. This cooperative agreement seeks to fund organizations that reach clinical specialties, healthcare provider groups (e.g., doctors, physical therapists, nurses, nurse assistants), and/or occupational groups (e.g., sanitation workers, hospital associations, correctional health care workers, purchasing organizations, facility design and engineering associations, entomologists, vector control professionals, and occupational health and safety professional associations) to ensure the development, adaptation, and use of infection prevention and control guidance for improved public health outcomes.

a. Health Disparities

9 of 46

This cooperative agreement includes program activities that can be used to target occupational groups that serve populations at disproportionate risk of infectious disease and/or adverse outcomes. In targeting specialty and subspecialty organizations, efforts could reach groups that are currently unable to access guidance for the prevention and control of emerging or re-emerging infectious diseases. In addition, CDC seeks to fund organizations that specialize in reaching populations that may be lower income, in rural areas without easy access to healthcare or other healthcare organizations, and/or members of racial and ethnic minority communities who have been put at increased risk for higher rates of preventable infectious diseases or adverse outcomes. Applicants should have a plan in place to be inclusive of these populations that may be directly impacted or have increased risk for various infectious diseases, including but not limited to rural and native populations with disabilities; justice-involved; non-English speaking populations; lesbian, gay, bisexual, and transgender (LGBT) populations; people with limited health literacy; immunocompromised persons; and/or other populations with increased risk.

iv. Funding Strategy The funding strategy is designed to collect proposals from approved applicants and designate them as “approved but unfunded” (ABU). The NOFO will only be funded upon program identification of a public health need to address an emerging or re-emerging infectious disease threat. Depending on the nature of the threat, specific applicants and specific components of their applications will be selected for funding. These funding decisions will take into account various relevant factors such as geographic location of the emergency, expectations of spread, applicant’s capabilities, national priorities, etc. Recipients may be funded out of rank order, depending on the infectious disease threat. Recipients will be provided with an opportunity to develop a customized project plan that builds off of their initial project plan, once the infectious disease threat is identified.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The evaluation and performance measurement will help demonstrate achievement of program outcomes; build a stronger evidence base for specific program strategies; clarify applicability of the evidence base to different populations, settings, and contexts; and drive continuous program improvement. Evaluation findings and performance measures will be used to demonstrate the value of this program and describe effective implementation of the NOFO. Recipients will be responsible for data collection and reporting. Recipients will submit to CDC the required data and any other information required. These data and information will be used by CDC to monitor indicators, document progress, and generate feedback reports regarding program accomplishments. At the core of the evaluation and performance measure strategy is a set of process measures and outputs to track implementation of the strategies, and outcome measures to monitor achievement of the outcomes expected in the period of performance. Proposed process measures for an applicant’s performance plan might include: DISSEMINATE AND ADOPT:

10 of 46

1. Proportion of priority best practices, clinical guidelines documents, or guidance documents released from CDC and promoted/disseminated by the recipient within 2 weeks of release

2. Number of dissemination networks and dissemination plans to reach target audiences with desired information (reporting metric: plan, network map, target audience analysis, or other outcome of an activity designed to determine reach and penetrance)

INFORM AND ADAPT:

1. Number of key stakeholder engagement meetings (formal and informal) held in advance of guidance development or adaptation

2. Number of new best practices/guidance documents that are vetted by the target audience’s practitioners/specialists before release

3. Number of existing guidance documents that were adapted to incorporate input from the target audience

TARGET AND TRAIN:

1. Number of trainings held to educate the target audience for the guidance or recommendation

2. Number of training tools (modules, online courses, guidance documents, etc.) created during period of performance

INTEGRATE AND EXTEND:

1. Number of target audience engaged in rapid or living learning networks to connect specialists and share promising practices

2. Development of tools to engage underrepresented populations; integration of feedback from target populations into guidance documents, etc

3. Number of designs/plans developed to expand the reach of public health guidance to populations who have been put at increased risk for higher rates of preventable infectious diseases

4. Number of guidance documents that contain materials designed to address disparities and extend the reach of dissemination activities to rural and/or low-income audiences

EVALUATE AND IMPROVE:

1. Number of process evaluations conducted, assessing program evaluation metrics (above) 2. Evaluation findings are included in performance monitoring reports to CDC

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

11 of 46

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both). Describe key evaluation questions to be addressed by these evaluations. Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Given the wide range of potential recipients and their target audiences, evaluations plans will have to be tailored if and when partners are funded by CDC programs. However, each evaluation plan will include some elements that are consistent across recipients (as outlined in the logic model). Funding recipients will be required to provide regular output measures that indicate programmatic progress towards the strategy(ies) their work fulfills. Applicant Evaluation and Performance Measurement Plan will be developed in concert with CDC based on the nature of the event. Companion guidance will be released by CDC with Public Health threat-specific guidance.

c. Organizational Capacity of Recipients to Implement the Approach Applicants must possess the organizational capacity and skills needed to implement the award including the capability to:

Reach a national or regional network of an occupational category(ies) that is an integral part of the prevention and control of emerging or re-emerging infectious disease;

Implement a functional response to a public health threat, including distributing public

12 of 46

health guidance, recommendations, and tools and providing support to implement these resources.

Inform, educate, and empower frontline staff engaged in the prevention and control of infectious diseases.

Assemble and provide individual expert opinions from occupational groups regarding opportunities for adaptations to existing public health guidance, recommendations, and tools to achieve more successful implementation.

In support of these capabilities, applicants must provide documentation on their capacity to implement the required activities and provide information that:

Demonstrates existing organizational capacity for program and staffing management; performance measurement, and evaluation systems; financial reporting systems; communication, technological, and data systems required to implement the activities in an effective and expedited manner; physical infrastructure and equipment; and workforce capacity to successfully execute all proposed strategies and activities based on the planning scenario.

Demonstrates the organizational capacity to manage partnerships with other organizations to ensure a coordinated response to the identified public health threat.

Depicts the current organizational chart for their public health program.

Recipients must have the ability to (1) submit an amended budget within 14 days of notice of CDC’s intent to make an award, (2) procure equipment, services, etc., (3) hire or contract for temporary staffing, and (4) execute a contract within 30 days. Applicants must agree to submit quarterly spend reports for any awards made under this NOFO. Applicants must provide copies of organizational charts for their organization and relevant public health programs within their structure. A letter signed by the organization’s President or CEO on organization letterhead, attesting to the existing capacity and capability for rapid procurement, hiring, and contracting is also required. Applicants may not be recipients of existing CDC cooperative agreements in a similar focus area or capacity. Applicants must name the files “Organizational Chart,” “PH Program Organizational Chart,” and “Administrative Requirement Capability Letter”. Applicants must upload them as PDF files at www.grants.gov.

d. Work Plan Planning Scenario: For planning purposes, applicants should develop their work plans to address the capabilities required to respond to a scenario involving the emergence or re-emergence of an infectious disease. The work plan should address the activities related to two or more of the program strategies. Applicants should assume that response to the threat is supported by interim guidance, recommendations, or tools released by CDC for general healthcare providers and occupational groups engaged in the prevention and control of the infectious disease. Negative outcomes of the infectious disease are often associated with select socio-economic groups, including racial and

13 of 46

ethnic minorities, those with disabilities, and those living in rural areas. The emerging infectious disease has a high rate of attack and hospitalization rate, and either a countermeasure and/or pharmaceutical and/or vector control and/or an oral prophylaxes component. General Work Plan Guidance: Applicants must develop and submit a high-level work plan that addresses the proposed scenario. The plans and activities should align with the program strategies in the logic model. Applicants should be able to revise the plans and activities in the work plan based on supplement guidance issued by CDC for an identified public health threat. The high-level plan should reflect the strategies, outcomes, evaluation, and performance measures described in the NOFO. Recipients must provide at least one proposed long-term outcome. The proposed short-term and intermediate outcomes should directly relate to the expected results of completing the planned response activity. Planned activities must be associated with functions or objectives related to the program strategy(ies).

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes. Ensuring the adequacy of recipient systems that underlie and generate data reports. Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

For any set of activities funded under this NOFO, recipients should collaborate closely with the Division of Healthcare Quality and Promotion’s project officers and sponsor CDC programs as well as other organizations funded by CDC to address the public health threat, as appropriate. Other activities deemed necessary to monitor the award, if applicable; these activities may

14 of 46

include monitoring and reporting activities that assist grants management staff (e.g., grants management officers, specialists, and project officers) in the identification, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO COOPERATIVE AGREEMENTS) In this cooperative agreement, CDC staff will be substantially involved in the program activities beyond routine grant monitoring. CDC’s National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality and Promotion (DHQP) project officers and subject matter experts will work with other Division and CIO subject matter experts that may serve in a technical monitoring role for specific activities, segments, or aspects of a specific public health threat. DHQP will coordinate the review of applications to ensure activities are in scope and do not duplicate those funded by other CDC cooperative agreements. CDC will use application submission information to identify strengths and weaknesses, coordinate with the applicant to update work plans, and to establish priorities for site visits and technical assistance. To assist recipients in achieving the purpose of this award, CDC will conduct the following activities.

1. Provide ongoing guidance, programmatic support, training, and technical assistance as related to activities outlined in this funding announcement.

2. Conduct conference calls, site visits, and other communications as applicable with recipients.

3. Facilitate communication among recipients to advance the sharing of expertise on response activities.

4. Coordinate planning and implementation activities with other organizational and/or federal partners as needed, based on the specific public health threat.

B. Award Information 1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this

program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U50 Special Cooperative Investigations/Assessment of Control/Prevention Methods

3. Fiscal Year: 2020 4. Approximate Total Fiscal Year Funding: $10,000,000 5. Approximate Period of Performance Funding: $0

This amount is subject to the availability of funds. This amount is subject to the availability of funds. It is not possible to approximate an amount of funding due to the nature of this NOFO (i.e., the intent to establish a quick funding

15 of 46

mechanism for pre-approved recipients faced with a public health threat).

Estimated Total Funding: $0 6. Approximate Period of Performance Length: 5 year(s) 7. Expected Number of Awards: 24 Approximately 5-10 applicants will initially be awarded in response to this NOFO. The initial recipients will respond to at least two of five program strategies in response to COVID-19. All other approved applicants will be added to the ABU roster listing. ABUs will be funded in response to other emerging and re-emerging public health threats as the need arise. Applicants may apply for 2 and/or any combination of the 5 strategies.

8. Approximate Average Award: $1,000,000 Per Budget Period 9. Award Ceiling: $0 Per Budget Period

This amount is subject to the availability of funds. This amount is subject to the availability of funds. No ceiling is established for the outset of this NOFO. CDC may establish a ceiling when a public health threat is identified and supplemental guidance will provide additional information on this topic

10. Award Floor: $0 Per Budget Period For planning and budgeting purposes, one may use $1,000,000 for the initial budget period.

11. Estimated Award Date: 09/30/2020 12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is available through this NOFO.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments

16 of 46

Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category: Government Organizations: State governments or their bona fide

agents (includes the District of Columbia)

Local governments or their bona fide agents

Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

17 of 46

State controlled institutions of higher education

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations: American Indian or Alaska native

tribally designated organizations Other: Ministries of Health

2. Additional Information on Eligibility All organizations are eligible.

3. Justification for Less than Maximum Competition N/A

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No No. Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov. a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements. The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

18 of 46

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds. b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/. c. Grants.gov: The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov. All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up 1 Data

Universal Number System (DUNS)

1. Click on http:// fedgov.dnb.com/ webform 2. Select Begin DUNS search/request process 3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit # 4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for Award Management (SAM) formerly Central Contractor Registration (CCR)

1. Retrieve organizations DUNS number 2. Go to https://www.sam.gov/SAM/ and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls: 866-606-8220

19 of 46

you can register on grants.gov)

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR) 2. Once the account is set up the E-BIZ POC will be notified via email 3. Log into grants.gov using the password the E-BIZ POC received and create new password 4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying on grants.gov)

Register early! Log into grants.gov and check AOR status until it shows you have been approved

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 07/14/2020

b. Application Deadline Due Date for Applications: 07/31/2020 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first

20 of 46

business day on which grants.gov operations resume.

Date for Information Conference Call July 7, 2020 at 4:00 PM – 5:00 PM ET https://cdc.zoomgov.com/j/1612701276?pwd=VytvRXI0aGFYWGJ4Um5lb1ord3BEdz09 Password: CK20-2003 Or Telephone: Dial(for higher quality, dial a number based on your current location): US: +1 669 254 5252 or +1 646 828 7666 Webinar ID: 161 270 1276, Password: 580384 International numbers available: https://cdc.zoomgov.com/u/acI3CElOyH

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx. Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date. Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

21 of 46

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920-1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS. When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy. Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source. Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award. Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent Letter of Intent is Requested but Optional The purpose of an LOI is to allow CDC program staff to estimate the number of and plan for the review of submitted applications. Failure to submit LOI will not impact review of application.

22 of 46

LOI should be sent via email to: Shanda Blue CDC, NCEZID Address: MS H16-5, 1600 Clifton Road Telephone number: 404-639-1709 Fax: 404-718-1900 Email address: [email protected] Please Cc: Robert Williams Grants Management Specialist Office of Grants Services 2939 Flowers Road, MS TV-2 Atlanta, GA 30341 Email address: [email protected]

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package. Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative

23 of 46

(Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.) Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description. Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period. See the Strategies and Activities section of the CDC Project Description.

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

24 of 46

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see https://www.cdc.gov/od/science/integrity/reducePublicBurden/.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both). Describe key evaluation questions to be addressed by these evaluations. Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan (including the DMP elements) within the first 6 months of award, as described in the Reporting Section of this NOFO.

d. Organizational Capacity of Applicants to Implement the Approach Applicants must address the organizational capacity requirements as described in the CDC

25 of 46

Project Description.

11. Work Plan (Included in the Project Narrative’s page limit) Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative Applicants must submit an itemized budget narrative. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs could include the cost of collecting, managing, sharing and preserving data. Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization. If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this NOFO to meet national standards or seek health department accreditation through the Public Health Accreditation Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated

26 of 46

organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the NOFO. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed. Vital records data, including births and deaths, are used to inform public health program and policy decisions. If applicable and consistent with the cited statutory authority for this NOFO, applicant entities are encouraged to collaborate with and support their jurisdiction’s vital records office (VRO) to improve vital records data timeliness, quality and access, and to advance public health goals. Recipients may, for example, use funds to support efforts to build VRO capacity through partnerships; provide technical and/or financial assistance to improve vital records timeliness, quality or access; or support vital records improvement efforts, as approved by CDC. Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Recipients under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

The budget narrative should be structured at a high level, addressing those activities associated with the prevention and control of an emerging or re-emerging infectious disease threat. It should address how the funding will not be duplicative of other federal funding, e.g., CSTLTS; it should address new activities that will improve the impact of public health efforts; and other identified issues that the applicant thinks will be critical to responding to the public health threat. The budget narrative should utilize real costs from previous, related activities such as response to H1N1, Ebola, Zika, or COVID-19 to the extent practical. Recipients must provide sub-recipient contracts, if applicable.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds. Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards. Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Recipients will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide recipients and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

27 of 46

Records that identify adequately the source and application of funds for federally-funded activities.

Effective control over, and accountability for, all funds, property, and other assets. Comparison of expenditures with budget amounts for each Federal award. Written procedures to implement payment requirements. Written procedures for determining cost allowability. Written procedures for financial reporting and monitoring.

14. Intergovernmental Review Executive Order 12372 does not apply to this program.

15. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition that applies the terms of 48 Code of Federal Regulations (CFR) section 3.908 to the award and requires that recipients inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

16. Copyright Interests Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision. The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed

28 of 46

Central identification number (PMCID) thereafter.

17. Funding Restrictions Restrictions that must be considered while planning the programs and writing the budget are:

Recipients may not use funds for research. Recipients may not use funds for clinical care except as allowed by law. Recipients may use funds only for reasonable program purposes, including personnel,

travel, supplies, and services. Generally, recipients may not use funds to purchase furniture or equipment. Any such

proposed spending must be clearly identified in the budget. Reimbursement of pre-award costs generally is not allowed, unless the CDC provides

written approval to the recipient. Other than for normal and recognized executive-legislative relationships, no funds may

be used for: o publicity or propaganda purposes, for the preparation, distribution, or use of any

material designed to support or defeat the enactment of legislation before any legislative body

o the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC recipients.

The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project outcomes and not merely serve as a conduit for an award to another party or provider who is ineligible.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability (https://www.cdc.gov/grants/additionalrequirements/ar-35.html).

Additional information applicable to Covid19 Additional Term and Condition: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief,

29 of 46

and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); and/or the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation. In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement. This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward. Funding source is not yet established and will be determined at the time CDC decides to implement the NOFO, additional funding restrictions may be added as required by appropriation language used to make awards.

18. Data Management Plan As identified in the Evaluation and Performance Measurement section, applications involving data collection must include a Data Management Plan (DMP) as part of their evaluation and performance measurement plan. The DMP is the applicant’s assurance of the quality of the public health data through the data’s lifecycle and plans to deposit data in a repository to preserve and to make the data accessible in a timely manner. See web link for additional information: https://www.cdc.gov/grants/additionalrequirements/ar-25.html

19. Other Submission Requirements a. Electronic Submission: Applications must be submitted electronically by using the forms and instructions posted for this notice of funding opportunity at www.grants.gov. Applicants can complete the application package using Workspace, which allows forms to be filled out online or offline. All application attachments must be submitted using a PDF file format. Instructions and training for using Workspace can be found at www.grants.gov under the "Workspace Overview" option.

30 of 46

b. Tracking Number: Applications submitted through www.grants.gov are time/date stamped electronically and assigned a tracking number. The applicant’s Authorized Organization Representative (AOR) will be sent an e-mail notice of receipt when www.grants.gov receives the application. The tracking number documents that the application has been submitted and initiates the required electronic validation process before the application is made available to CDC. c. Validation Process: Application submission is not concluded until the validation process is completed successfully. After the application package is submitted, the applicant will receive a “submission receipt” e-mail generated by www.grants.gov. A second e-mail message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted application package. This validation process may take as long as two business days. Applicants are strongly encouraged to check the status of their application to ensure that submission of their package has been completed and no submission errors have occurred. Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted and validated by the deadline published in the NOFO. Non-validated applications will not be accepted after the published application deadline date. If you do not receive a “validation” e-mail within two business days of application submission, please contact www.grants.gov. For instructions on how to track your application, refer to the e-mail message generated at the time of application submission or the Grants.gov Online User Guide. https:// www.grants.gov/help/html/help/index.htm? callingApp=custom#t= Get_Started%2FGet_Started. htm d. Technical Difficulties: If technical difficulties are encountered at www.grants.gov, applicants should contact Customer Service at www.grants.gov. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. The Contact Center is available by phone at 1-800-518-4726 or by e-mail at [email protected]. Application submissions sent by e-mail or fax, or on CDs or thumb drives will not be accepted. Please note that www.grants.gov is managed by HHS. e. Paper Submission: If technical difficulties are encountered at www.grants.gov, applicants should call the www.grants.gov Contact Center at 1-800-518-4726 or e-mail them at [email protected] for assistance. After consulting with the Contact Center, if the technical difficulties remain unresolved and electronic submission is not possible, applicants may e-mail CDC GMO/GMS, before the deadline, and request permission to submit a paper application. Such requests are handled on a case-by-case basis. An applicant’s request for permission to submit a paper application must:

1. Include the www.grants.gov case number assigned to the inquiry 2. Describe the difficulties that prevent electronic submission and the efforts taken with

the www.grants.gov Contact Center to submit electronically; and 3. Be received via e-mail to the GMS/GMO listed below at least three calendar days before

the application deadline. Paper applications submitted without prior approval will not be considered.

31 of 46

If a paper application is authorized, OGS will advise the applicant of specific instructions for submitting the application (e.g., original and two hard copies of the application by U.S. mail or express delivery service).

E. Review and Selection Process

1. Review and Selection Process: Applications will be reviewed in three phases

a. Phase 1 Review All applications will be initially reviewed for eligibility and completeness by CDC Office of Grants Services. Complete applications will be reviewed for responsiveness by the Grants Management Officials and Program Officials. Non-responsive applications will not advance to Phase II review. Applicants will be notified that their applications did not meet eligibility and/or published submission requirements.

b. Phase II Review A review panel will evaluate complete, eligible applications in accordance with the criteria below. i. Approach ii. Evaluation and Performance Measurement iii. Applicant’s Organizational Capacity to Implement the Approach Not more than thirty days after the Phase II review is completed, applicants will be notified electronically if their application does not meet eligibility or published submission requirements.

i. Approach Maximum Points:35

Does the applicant clearly identify their target population? (6 points) How clearly does the work plan identify and quantify existing operational gaps and the

root cause of the gaps to be addressed within the target population? (6 points) To what extent does the applicant clearly describe their proposed approach to

accomplish activities in support of at least two program strategies? (6 points) Has the applicant described their approach to engage target populations that are at

increased risk for infectious diseases? (6 points) Has the applicant included estimated timelines for completion of all performance and

work plan activities as well as obligation and liquidation of funds within the budget and period of performance? (6 points)

To what extent does the applicant provide evidence for the likely success of their proposed approach? (5 points)

ii. Evaluation and Performance Measurement Maximum Points:25

For each targeted program strategy, how well do the planned activities (short-term,

32 of 46

intermediate, or long-term) align with successfully addressing the problem or gap within the target population? (10 points)

To what extent is evidence provided that demonstrates that the activities and outcomes can be achieved during the period of performance? (5 points)

How clearly does the evaluation and performance monitoring plan include the assessment and monitoring of appropriate performance metrics? (10 points)

iii. Applicant's Organizational Capacity to Implement the Approach

Maximum Points:40

To what extent does the applicant describe in detail the type(s) of occupational categories they can reach, the extent of their reach, and how the organization relates to the prevention and control of infectious diseases in the US.? (5 points)

To what extent does the applicant demonstrate existing organizational capacity to implement a functional response to a public health threat, including distributing public health guidance, recommendations, and tools and providing support to implement these resources? (8 points)

To what extent does the applicant demonstrate the organizational capacity to inform, educate, and empower frontline staff engaged in the prevention and control of infectious diseases? (5 points)

To what extent does the applicant demonstrate the organizational capacity to assemble and provide individual expert opinions from occupational groups to achieve more successful implementation of public health recommendations and tools? (5 points)

To what extent does the applicant provide evidence of existing organizational capacity for program and staffing management; performance measurement, and evaluation systems; financial reporting systems; communication, technological, and data systems required to implement the activities in an effective and expedited manner; physical infrastructure and equipment; and workforce capacity to successfully execute all proposed strategies and activities based on the planning scenario. (7 points)

Demonstrates the organizational capacity to manage partnerships with other organizations to ensure a coordinated response to the identified public health threat. (5 points)

Does the applicant provide a clear organizational chart that is relevant for completion of the proposed project plan? (5 points)

Budget To what extent is the proposed budget consistent with stated program strategies and planned program activities? To what extent is the proposed budget adequately justified?

c. Phase III Review

33 of 46

All applicants will be subject to CDC’s standard objective review process using the criteria identified above. In order to successfully implement a national strategy to combat public health threats, CDC recognizes the need to fund out of rank order based on the nature of the emergency, geographic need, disease burden, and/or populations disproportionately impacted by public health emergencies This funding opportunity will result in a list of ABU organizations. Any funding tied to this NOFO will only be made available once CDC has determined a public health threat exists. Thus, there is limited funding available at the time of this announcement. Additional funding will be contingent upon the availability of appropriations and is at CDC’s sole discretion.

Review of risk posed by applicants. Prior to making a Federal award, CDC is required by 31 U.S.C. 3321 and 41 U.S.C. 2313 to review information available through any OMB-designated repositories of government-wide eligibility qualification or financial integrity information as appropriate. See also suspension and debarment requirements at 2 CFR parts 180 and 376. In accordance 41 U.S.C. 2313, CDC is required to review the non-public segment of the OMB-designated integrity and performance system accessible through SAM (currently the Federal Recipient Performance and Integrity Information System (FAPIIS)) prior to making a Federal award where the Federal share is expected to exceed the simplified acquisition threshold, defined in 41 U.S.C. 134, over the period of performance. At a minimum, the information in the system for a prior Federal award recipient must demonstrate a satisfactory record of executing programs or activities under Federal grants, cooperative agreements, or procurement awards; and integrity and business ethics. CDC may make a Federal award to a recipient who does not fully meet these standards, if it is determined that the information is not relevant to the current Federal award under consideration or there are specific conditions that can appropriately mitigate the effects of the non-Federal entity's risk in accordance with 45 CFR §75.207. CDC’s framework for evaluating the risks posed by an applicant may incorporate results of the evaluation of the applicant's eligibility or the quality of its application. If it is determined that a Federal award will be made, special conditions that correspond to the degree of risk assessed may be applied to the Federal award. The evaluation criteria is described in this Notice of Funding Opportunity. In evaluating risks posed by applicants, CDC will use a risk-based approach and may consider any items such as the following: (1) Financial stability; (2) Quality of management systems and ability to meet the management standards prescribed in this part; (3) History of performance. The applicant's record in managing Federal awards, if it is a prior recipient of Federal awards, including timeliness of compliance with applicable reporting requirements, conformance to the terms and conditions of previous Federal awards, and if applicable, the extent to which any previously awarded amounts will be expended prior to future awards; (4) Reports and findings from audits performed under subpart F 45 CFR 75 or the reports and findings of any other available audits; and (5) The applicant's ability to effectively implement statutory, regulatory, or other requirements

34 of 46

imposed on non-Federal entities. CDC must comply with the guidelines on government-wide suspension and debarment in 2 CFR part 180, and require non-Federal entities to comply with these provisions. These provisions restrict Federal awards, subawards and contracts with certain parties that are debarred, suspended or otherwise excluded from or ineligible for participation in Federal programs or activities.

2. Announcement and Anticipated Award Dates

Announcement: July 1st; application process closes July 31th; funds disbursed to select recipients by September 30th. CDC will provide additional information regarding when and how the awards will be announced, as determined by the emerging or re-emerging public health threat. While email from the Grants Management Office will be the official route of communications, additional communications will be made through a variety of media to ensure awareness by ABU organizations that CDC will be implementing the provisions of this NOFO.

F. Award Administration Information

1. Award Notices Recipients will receive an electronic copy of the Notice of Award (NOA) from CDC OGS. The NOA shall be the only binding, authorizing document between the recipient and CDC. The NOA will be signed by an authorized GMO and emailed to the Recipient Business Officer listed in application and the Program Director. Any applicant awarded funds in response to this Notice of Funding Opportunity will be subject to the DUNS, SAM Registration, and Federal Funding Accountability And Transparency Act Of 2006 (FFATA) requirements. Unsuccessful applicants will receive notification of these results by e-mail with delivery receipt or by U.S. mail.

2. Administrative and National Policy Requirements Recipients must comply with the administrative and public policy requirements outlined in 45 CFR Part 75 and the HHS Grants Policy Statement, as appropriate. Brief descriptions of relevant provisions are available at http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-17. The HHS Grants Policy Statement is available at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

Funding source is not yet established and will be determined at the time CDC decides to implement this NOFO; the list of administrative and national policy requirements may need to be amended to bring into compliance.

35 of 46

The full text of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, 45 CFR 75, can be found at: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75

3. Reporting Reporting provides continuous program monitoring and identifies successes and challenges that recipients encounter throughout the project period. Also, reporting is a requirement for recipients who want to apply for yearly continuation of funding. Reporting helps CDC and recipients because it:

Helps target support to recipients; Provides CDC with periodic data to monitor recipient progress toward meeting

the Notice of Funding Opportunity outcomes and overall performance; Allows CDC to track performance measures and evaluation findings for continuous

quality and program improvement throughout the period of performance and to determine applicability of evidence-based approaches to different populations, settings, and contexts; and

Enables CDC to assess the overall effectiveness and influence of the NOFO.

The table below summarizes required and optional reports. All required reports must be sent electronically to GMS listed in the “Agency Contacts” section of the NOFO copying the CDC Project Officer.

Report When? Required?

Recipient Evaluation and Performance Measurement Plan, including Data Management Plan (DMP)

6 months into award Yes

Annual Performance Report (APR)

No later than 120 days before end of budget period. Serves as yearly continuation application.

Yes

Federal Financial Reporting Forms

90 days after the end of the budget period Yes

Final Performance and Financial Report

90 days after end of period of performance Yes

Payment Management System (PMS) Reporting

Quarterly reports due January 30; April 30; July 30; and October 30

Yes

36 of 46

a. Recipient Evaluation and Performance Measurement Plan (required) With support from CDC, recipients must elaborate on their initial applicant evaluation and performance measurement plan. This plan must be no more than 20 pages; recipients must submit the plan 6 months into the award. HHS/CDC will review and approve the recipient’s monitoring and evaluation plan to ensure that it is appropriate for the activities to be undertaken as part of the agreement, for compliance with the monitoring and evaluation guidance established by HHS/CDC, or other guidance otherwise applicable to this Agreement. Recipient Evaluation and Performance Measurement Plan (required): This plan should provide additional detail on the following: Performance Measurement • Performance measures and targets • The frequency that performance data are to be collected. • How performance data will be reported. • How quality of performance data will be assured. • How performance measurement will yield findings to demonstrate progress towards achieving NOFO goals (e.g., reaching target populations or achieving expected outcomes). • Dissemination channels and audiences. • Other information requested as determined by the CDC program. Evaluation • The types of evaluations to be conducted (e.g. process or outcome evaluations). • The frequency that evaluations will be conducted. • How evaluation reports will be published on a publically available website. • How evaluation findings will be used to ensure continuous quality and program improvement. • How evaluation will yield findings to demonstrate the value of the NOFO (e.g., effect on improving public health outcomes, effectiveness of NOFO, cost-effectiveness or cost-benefit). • Dissemination channels and audiences. HHS/CDC or its designee will also undertake monitoring and evaluation of the defined activities within the agreement. The recipient must ensure reasonable access by HHS/CDC or its designee to all necessary sites, documentation, individuals and information to monitor, evaluate and verify the appropriate implementation the activities and use of HHS/CDC funding under this Agreement.

b. Annual Performance Report (APR) (required) The recipient must submit the APR via www.Grantsolutions.gov no later than120 days prior to the end of the budget period. This report must not exceed 45 pages excluding administrative reporting. Attachments are not allowed, but web links are allowed. This report must include the following:

Performance Measures: Recipients must report on performance measures for each

37 of 46

budget period and update measures, if needed. Evaluation Results: Recipients must report evaluation results for the work completed to

date (including findings from process or outcome evaluations). Work Plan: Recipients must update work plan each budget period to reflect any

changes in period of performance outcomes, activities, timeline, etc. Successes

o Recipients must report progress on completing activities and progress towards achieving the period of performance outcomes described in the logic model and work plan.

o Recipients must describe any additional successes (e.g. identified through evaluation results or lessons learned) achieved in the past year.

o Recipients must describe success stories. Challenges

o Recipients must describe any challenges that hindered or might hinder their ability to complete the work plan activities and achieve the period of performance outcomes.

o Recipients must describe any additional challenges (e.g., identified through evaluation results or lessons learned) encountered in the past year.

CDC Program Support to Recipients o Recipients must describe how CDC could help them overcome challenges to

complete activities in the work plan and achieving period of performance outcomes.

Administrative Reporting (No page limit) o SF-424A Budget Information-Non-Construction Programs. o Budget Narrative – Must use the format outlined in "Content and Form of

Application Submission, Budget Narrative" section. o Indirect Cost Rate Agreement.

N/A

The recipients must submit the Annual Performance Report via www.Grantsolutions.gov no later than 120 days prior to the end of the budget period.

c. Performance Measure Reporting (optional) CDC programs may require more frequent reporting of performance measures than annually in the APR. If this is the case, CDC programs must specify reporting frequency, data fields, and format for recipients at the beginning of the award period.

N/A

d. Federal Financial Reporting (FFR) (required) The annual FFR form (SF-425) is required and must be submitted 90 days after the end of the budget period. The report must include only those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds, and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System’s (PMS) cash

38 of 46

transaction data. Failure to submit the required information by the due date may adversely affect the future funding of the project. If the information cannot be provided by the due date, recipients are required to submit a letter of explanation to OGS and include the date by which the Grants Officer will receive information.

N/A

e. Final Performance and Financial Report (required) This report is due 90 days after the end of the period of performance. CDC programs must indicate that this report should not exceed 40 pages. This report covers the entire period of performance and can include information previously reported in APRs. At a minimum, this report must include the following:

Performance Measures – Recipients must report final performance data for all process and outcome performance measures.

Evaluation Results – Recipients must report final evaluation results for the period of performance for any evaluations conducted.

Impact/Results/Success Stories – Recipients must use their performance measure results and their evaluation findings to describe the effects or results of the work completed over the project period, and can include some success stories.

A final Data Management Plan that includes the location of the data collected during the funded period, for example, repository name and link data set(s)

Additional forms as described in the Notice of Award (e.g., Equipment Inventory Report, Final Invention Statement).

This report is due 90 days after the end of the period of performance. CDC programs must indicate that this report should not exceed 40 pages. This report covers the entire period of performance and can include information previously reported in APRs. At a minimum, this report must include the following: Performance Measures – Recipients must report final performance data for all process and outcome performance measures. Evaluation Results – Recipients must report final evaluation results for the period of performance for any evaluations conducted. Impact/Results/Success Stories – Recipients must use their performance measure results and their evaluation findings to describe the effects or results of the work completed over the period of performance, and can include some success stories. A final Data Management Plan that includes the location of the data collected during the funded period, for example, repository name and link data set(s) Additional forms as described in the Notice of Award (e.g., Equipment Inventory Report, Final Invention Statement).

4. Federal Funding Accountability and Transparency Act of 2006 (FFATA) Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252 requires full disclosure of all entities and

39 of 46

organizations receiving Federal funds including awards, contracts, loans, other assistance, and payments through a single publicly accessible Web site, http://www.USASpending.gov. Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by applicants: 1) information on executive compensation when not already reported through the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000. For the full text of the requirements under the FFATA and HHS guidelines, go to:

https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, https://www. fsrs.gov/documents /ffata_legislation_ 110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

5. Reporting of Foreign Taxes (International/Foreign projects only) A. Valued Added Tax (VAT) and Customs Duties – Customs and import duties, consular fees, customs surtax, valued added taxes, and other related charges are hereby authorized as an allowable cost for costs incurred for non-host governmental entities operating where no applicable tax exemption exists. This waiver does not apply to countries where a bilateral agreement (or similar legal document) is already in place providing applicable tax exemptions and it is not applicable to Ministries of Health. Successful applicants will receive information on VAT requirements via their Notice of Award. B. The U.S. Department of State requires that agencies collect and report information on the amount of taxes assessed, reimbursed and not reimbursed by a foreign government against commodities financed with funds appropriated by the U.S. Department of State, Foreign Operations and Related Programs Appropriations Act (SFOAA) (“United States foreign assistance funds”). Outlined below are the specifics of this requirement: 1) Annual Report: The recipient must submit a report on or before November 16 for each foreign country on the amount of foreign taxes charged, as of September 30 of the same year, by a foreign government on commodity purchase transactions valued at 500 USD or more financed with United States foreign assistance funds under this grant during the prior United States fiscal year (October 1 – September 30), and the amount reimbursed and unreimbursed by the foreign government. [Reports are required even if the recipient did not pay any taxes during the reporting period.] 2) Quarterly Report: The recipient must quarterly submit a report on the amount of foreign taxes charged by a foreign government on commodity purchase transactions valued at 500 USD or more financed with United States foreign assistance funds under this grant. This report shall be submitted no later than two weeks following the end of each quarter: April 15, July 15, October 15 and January 15. 3) Terms: For purposes of this clause: “Commodity” means any material, article, supplies, goods, or equipment; “Foreign government” includes any foreign government entity; “Foreign taxes” means value-added taxes and custom duties assessed by a foreign government

40 of 46

on a commodity. It does not include foreign sales taxes. 4) Where: Submit the reports to the Director and Deputy Director of the CDC office in the country(ies) in which you are carrying out the activities associated with this cooperative agreement. In countries where there is no CDC office, send reports to [email protected]. 5) Contents of Reports: The reports must contain: a. recipient name; b. contact name with phone, fax, and e-mail; c. agreement number(s) if reporting by agreement(s); d. reporting period; e. amount of foreign taxes assessed by each foreign government; f. amount of any foreign taxes reimbursed by each foreign government; g. amount of foreign taxes unreimbursed by each foreign government. 6) Subagreements. The recipient must include this reporting requirement in all applicable subgrants and other subagreements.

G. Agency Contacts

CDC encourages inquiries concerning this notice of funding opportunity.

Program Office Contact For programmatic technical assistance, contact:

Shanda Blue, Project Officer Department of Health and Human Services Centers for Disease Control and Prevention MS H16-5, 1600 Clifton Road

Telephone: (404) 639-1709 Email: [email protected]

Grants Staff Contact For financial, awards management, or budget assistance, contact:

Robert Williams, Grants Management Specialist Department of Health and Human Services Office of Grants Services 2939 Flowers Road, MS TV-2 Atlanta, GA 30341

Email: [email protected]

41 of 46

For assistance with submission difficulties related to www.grants.gov, contact the Contact Center by phone at 1-800-518-4726. Hours of Operation: 24 hours a day, 7 days a week, except on federal holidays. CDC Telecommunications for persons with hearing loss is available at: TTY 1-888-232-6348

H. Other Information

Following is a list of acceptable attachments applicants can upload as PDF files as part of their application at www.grants.gov. Applicants may not attach documents other than those listed; if other documents are attached, applications will not be reviewed.

Project Abstract Project Narrative Budget Narrative CDC Assurances and Certifications Report on Programmatic, Budgetary and Commitment Overlap Table of Contents for Entire Submission

For international NOFOs:

SF424 SF424A Funding Preference Deliverables

-Letter signed by the CEO or President of the organization on organizational letterhead attesting to the existing capacity and capability for rapid procurement, hiring, and contracting -Organizational chart reflecting organizational make up and placement of the public health program

I. Glossary

Activities: The actual events or actions that take place as a part of the program. Administrative and National Policy Requirements, Additional Requirements (ARs): Administrative requirements found in 45 CFR Part 75 and other requirements mandated by statute or CDC policy. All ARs are listed in the Template for CDC programs. CDC programs must indicate which ARs are relevant to the NOFO; recipients must comply with the ARs listed in the NOFO. To view brief descriptions of relevant provisions, see http:// www.cdc.gov/ grants/ additional requirements/ index.html. Note that 2 CFR 200 supersedes the administrative requirements (A-110 & A-102), cost principles (A-21, A-87 & A-122) and audit requirements (A-50, A-89 & A-133).

42 of 46

Approved but Unfunded: Approved but unfunded refers to applications recommended for approval during the objective review process; however, they were not recommended for funding by the program office and/or the grants management office. Assistance Listings (CFDA): A government-wide compendium published by the General Services Administration (available on-line in searchable format as well as in printable format as a .pdf file) that describes domestic assistance programs administered by the Federal Government. Assistance Listings (CFDA) Number: A unique number assigned to each program and NOFO throughout its lifecycle that enables data and funding tracking and transparency Award: Financial assistance that provides support or stimulation to accomplish a public purpose. Awards include grants and other agreements (e.g., cooperative agreements) in the form of money, or property in lieu of money, by the federal government to an eligible applicant. Budget Period or Budget Year: The duration of each individual funding period within the project period. Traditionally, budget periods are 12 months or 1 year. Carryover: Unobligated federal funds remaining at the end of any budget period that, with the approval of the GMO or under an automatic authority, may be carried over to another budget period to cover allowable costs of that budget period either as an offset or additional authorization. Obligated but liquidated funds are not considered carryover. CDC Assurances and Certifications: Standard government-wide grant application forms. Competing Continuation Award: A financial assistance mechanism that adds funds to a grant and adds one or more budget periods to the previously established period of performance (i.e., extends the “life” of the award). Continuous Quality Improvement: A system that seeks to improve the provision of services with an emphasis on future results. Contracts: An award instrument used to acquire (by purchase, lease, or barter) property or services for the direct benefit or use of the Federal Government. Cooperative Agreement: A financial assistance award with the same kind of interagency relationship as a grant except that it provides for substantial involvement by the federal agency funding the award. Substantial involvement means that the recipient can expect federal programmatic collaboration or participation in carrying out the effort under the award. Cost Sharing or Matching: Refers to program costs not borne by the Federal Government but by the recipients. It may include the value of allowable third-party, in-kind contributions, as well as expenditures by the recipient. Direct Assistance: A financial assistance mechanism, which must be specifically authorized by statute, whereby goods or services are provided to recipients in lieu of cash. DA generally involves the assignment of federal personnel or the provision of equipment or supplies, such as vaccines. DA is primarily used to support payroll and travel expenses of CDC employees assigned to state, tribal, local, and territorial (STLT) health agencies that are recipients of grants and cooperative agreements. Most legislative authorities that provide financial assistance to STLT health agencies allow for the use of DA. http:// www.cdc.gov /grants /additionalrequirements /index.html. DUNS: The Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number is a nine-digit number assigned by Dun and Bradstreet Information Services. When applying for Federal awards or cooperative agreements, all applicant organizations must obtain a DUNS number as the Universal Identifier. DUNS number assignment is free. If requested by telephone, a DUNS number will be provided immediately at no charge. If requested via the Internet,

43 of 46

obtaining a DUNS number may take one to two days at no charge. If an organization does not know its DUNS number or needs to register for one, visit Dun & Bradstreet at http://fedgov.dnb.com/ webform/displayHomePage.do. Evaluation (program evaluation): The systematic collection of information about the activities, characteristics, and outcomes of programs (which may include interventions, policies, and specific projects) to make judgments about that program, improve program effectiveness, and/or inform decisions about future program development. Evaluation Plan: A written document describing the overall approach that will be used to guide an evaluation, including why the evaluation is being conducted, how the findings will likely be used, and the design and data collection sources and methods. The plan specifies what will be done, how it will be done, who will do it, and when it will be done. The NOFO evaluation plan is used to describe how the recipient and/or CDC will determine whether activities are implemented appropriately and outcomes are achieved. Federal Funding Accountability and Transparency Act of 2006 (FFATA): Requires that information about federal awards, including awards, contracts, loans, and other assistance and payments, be available to the public on a single website at www.USAspending.gov. Fiscal Year: The year for which budget dollars are allocated annually. The federal fiscal year starts October 1 and ends September 30. Grant: A legal instrument used by the federal government to transfer anything of value to a recipient for public support or stimulation authorized by statute. Financial assistance may be money or property. The definition does not include a federal procurement subject to the Federal Acquisition Regulation; technical assistance (which provides services instead of money); or assistance in the form of revenue sharing, loans, loan guarantees, interest subsidies, insurance, or direct payments of any kind to a person or persons. The main difference between a grant and a cooperative agreement is that in a grant there is no anticipated substantial programmatic involvement by the federal government under the award. Grants.gov: A "storefront" web portal for electronic data collection (forms and reports) for federal grant-making agencies at www.grants.gov. Grants Management Officer (GMO): The individual designated to serve as the HHS official responsible for the business management aspects of a particular grant(s) or cooperative agreement(s). The GMO serves as the counterpart to the business officer of the recipient organization. In this capacity, the GMO is responsible for all business management matters associated with the review, negotiation, award, and administration of grants and interprets grants administration policies and provisions. The GMO works closely with the program or project officer who is responsible for the scientific, technical, and programmatic aspects of the grant. Grants Management Specialist (GMS): A federal staff member who oversees the business and other non-programmatic aspects of one or more grants and/or cooperative agreements. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with regulations and guidelines, negotiating grants, providing consultation and technical assistance to recipients, post-award administration and closing out grants. Health Disparities: Differences in health outcomes and their determinants among segments of the population as defined by social, demographic, environmental, or geographic category. Health Equity: Striving for the highest possible standard of health for all people and giving special attention to the needs of those at greatest risk of poor health, based on social conditions.

44 of 46

Health Inequities: Systematic, unfair, and avoidable differences in health outcomes and their determinants between segments of the population, such as by socioeconomic status (SES), demographics, or geography. Healthy People 2030: National health objectives aimed at improving the health of all Americans by encouraging collaboration across sectors, guiding people toward making informed health decisions, and measuring the effects of prevention activities. Inclusion: Both the meaningful involvement of a community’s members in all stages of the program process and the maximum involvement of the target population that the intervention will benefit. Inclusion ensures that the views, perspectives, and needs of affected communities, care providers, and key partners are considered. Indirect Costs: Costs that are incurred for common or joint objectives and not readily and specifically identifiable with a particular sponsored project, program, or activity; nevertheless, these costs are necessary to the operations of the organization. For example, the costs of operating and maintaining facilities, depreciation, and administrative salaries generally are considered indirect costs. Intergovernmental Review: Executive Order 12372 governs applications subject to Intergovernmental Review of Federal Programs. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following web address to get the current SPOC list: https://www.whitehouse.gov/wp-content/uploads/2017/11/Intergovernmental_-Review-_SPOC_01_2018_OFFM.pdf. Letter of Intent (LOI): A preliminary, non-binding indication of an organization’s intent to submit an application. Lobbying: Direct lobbying includes any attempt to influence legislation, appropriations, regulations, administrative actions, executive orders (legislation or other orders), or other similar deliberations at any level of government through communication that directly expresses a view on proposed or pending legislation or other orders, and which is directed to staff members or other employees of a legislative body, government officials, or employees who participate in formulating legislation or other orders. Grass roots lobbying includes efforts directed at inducing or encouraging members of the public to contact their elected representatives at the federal, state, or local levels to urge support of, or opposition to, proposed or pending legislative proposals. Logic Model: A visual representation showing the sequence of related events connecting the activities of a program with the programs’ desired outcomes and results. Maintenance of Effort: A requirement contained in authorizing legislation, or applicable regulations that a recipient must agree to contribute and maintain a specified level of financial effort from its own resources or other non-government sources to be eligible to receive federal grant funds. This requirement is typically given in terms of meeting a previous base-year dollar amount. Memorandum of Understanding (MOU) or Memorandum of Agreement (MOA): Document that describes a bilateral or multilateral agreement between parties expressing a convergence of will between the parties, indicating an intended common line of action. It is often used in cases where the parties either do not imply a legal commitment or cannot create a legally enforceable agreement. Nonprofit Organization: Any corporation, trust, association, cooperative, or other organization

45 of 46

that is operated primarily for scientific, educational, service, charitable, or similar purposes in the public interest; is not organized for profit; and uses net proceeds to maintain, improve, or expand the operations of the organization. Nonprofit organizations include institutions of higher educations, hospitals, and tribal organizations (that is, Indian entities other than federally recognized Indian tribal governments). Notice of Award (NoA): The official document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and (3) provides the documentary basis for recording the obligation of Federal funds in the HHS accounting system. Objective Review: A process that involves the thorough and consistent examination of applications based on an unbiased evaluation of scientific or technical merit or other relevant aspects of the proposal. The review is intended to provide advice to the persons responsible for making award decisions. Outcome: The results of program operations or activities; the effects triggered by the program. For example, increased knowledge, changed attitudes or beliefs, reduced tobacco use, reduced morbidity and mortality. Performance Measurement: The ongoing monitoring and reporting of program accomplishments, particularly progress toward pre-established goals, typically conducted by program or agency management. Performance measurement may address the type or level of program activities conducted (process), the direct products and services delivered by a program (outputs), or the results of those products and services (outcomes). A “program” may be any activity, project, function, or policy that has an identifiable purpose or set of objectives. Period of performance –formerly known as the project period - : The time during which the recipient may incur obligations to carry out the work authorized under the Federal award. The start and end dates of the period of performance must be included in the Federal award. Period of Performance Outcome: An outcome that will occur by the end of the NOFO’s funding period Plain Writing Act of 2010: The Plain Writing Act of 2010 requires that federal agencies use clear communication that the public can understand and use. NOFOs must be written in clear, consistent language so that any reader can understand expectations and intended outcomes of the funded program. CDC programs should use NOFO plain writing tips when writing NOFOs. Program Strategies: Strategies are groupings of related activities, usually expressed as general headers (e.g., Partnerships, Assessment, Policy) or as brief statements (e.g., Form partnerships, Conduct assessments, Formulate policies). Program Official: Person responsible for developing the NOFO; can be either a project officer, program manager, branch chief, division leader, policy official, center leader, or similar staff member. Public Health Accreditation Board (PHAB): A nonprofit organization that works to promote and protect the health of the public by advancing the quality and performance of public health departments in the U.S. through national public health department accreditation http://www.phaboard.org. Social Determinants of Health: Conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Statute: An act of the legislature; a particular law enacted and established by the will of the

46 of 46

legislative department of government, expressed with the requisite formalities. In foreign or civil law any particular municipal law or usage, though resting for its authority on judicial decisions, or the practice of nations. Statutory Authority: Authority provided by legal statute that establishes a federal financial assistance program or award. System for Award Management (SAM): The primary vendor database for the U.S. federal government. SAM validates applicant information and electronically shares secure and encrypted data with federal agencies' finance offices to facilitate paperless payments through Electronic Funds Transfer (EFT). SAM stores organizational information, allowing www.grants.gov to verify identity and pre-fill organizational information on grant applications. Technical Assistance: Advice, assistance, or training pertaining to program development, implementation, maintenance, or evaluation that is provided by the funding agency. Work Plan: The summary of period of performance outcomes, strategies and activities, personnel and/or partners who will complete the activities, and the timeline for completion. The work plan will outline the details of all necessary activities that will be supported through the approved budget.

NOFO-specific Glossary and Acronyms N/A